The Art And Science Of Dermal Formulation Development

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The Art and Science of Dermal Formulation Development

Marc B. Brown,Adrian C. Williams
The Art and Science of Dermal Formulation Development Book PDF

Author : Marc B. Brown,Adrian C. Williams
Publisher : CRC Press
Page : 248 pages
File Size : 45,9 Mb
Release : 2019-03-01
Category : Medical
ISBN : 9780429596063

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The Art and Science of Dermal Formulation Development by Marc B. Brown,Adrian C. Williams Pdf

The Art and Science of Dermal Formulation Development is a comprehensive guide to the theory and practice of transdermal and topical formulation development, covering preclinical studies, evaluation, and regulatory approval. It enables the reader to understand the opportunities and challenges in developing products and how risks can be mitigated. Over the last 25 years, expertise in this area has declined whilst drug delivery systems for other administration routes have developed significantly. The advantages offered by transdermal and topical drug delivery remain compelling for sectors including the pharmaceutical industry, personal care, and cosmetics. This text addresses the dearth of expertise and discusses how skin can be a route of delivery and the processes in formulation development, but how such an application is very different to that used for oral, IV, and other administration routes. Key Features: Presents a practical guide for both industry and academia Focuses on and draws together the fundamental principles behind transdermal and topical drug delivery Illustrates the practicalities of formulation design using key case studies Gives an understanding of the skin as a route of delivery and how formulation development for such application differs from that for other administration routes

The Art and Science of Dermal Formulation Development

Marc B. Brown,Adrian C. Williams
The Art and Science of Dermal Formulation Development Book PDF

Author : Marc B. Brown,Adrian C. Williams
Publisher : CRC Press
Page : 248 pages
File Size : 41,7 Mb
Release : 2019
Category : Medical
ISBN : 0429059876

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The Art and Science of Dermal Formulation Development by Marc B. Brown,Adrian C. Williams Pdf

The Art and Science of Dermal Formulation Development is a comprehensive guide to the theory and practice of transdermal and topical formulation development, covering preclinical studies, evaluation, and regulatory approval. It enables the reader to understand the opportunities and challenges in developing products and how risks can be mitigated. Over the last 25 years, expertise in this area has declined whilst drug delivery systems for other administration routes have developed significantly. The advantages offered by transdermal and topical drug delivery remain compelling for sectors including the pharmaceutical industry, personal care, and cosmetics. This text addresses the dearth of expertise and discusses how skin can be a route of delivery and the processes in formulation development, but how such an application is very different to that used for oral, IV, and other administration routes. Key Features: Presents a practical guide for both industry and academia Focuses on and draws together the fundamental principles behind transdermal and topical drug delivery Illustrates the practicalities of formulation design using key case studies Gives an understanding of the skin as a route of delivery and how formulation development for such application differs from that for other administration routes

Dermatological Drug Development

Tomoko Maeda-Chubachi,Elizabeth Kernodle Hussey,Sylvia Furst
Dermatological Drug Development Book PDF

Author : Tomoko Maeda-Chubachi,Elizabeth Kernodle Hussey,Sylvia Furst
Publisher : Cambridge Scholars Publishing
Page : 146 pages
File Size : 47,7 Mb
Release : 2020-09-18
Category : Medical
ISBN : 9781527559677

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Dermatological Drug Development by Tomoko Maeda-Chubachi,Elizabeth Kernodle Hussey,Sylvia Furst Pdf

This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and conducted. The drug development process is also an evolving strategy that is characterized by communicating, negotiating, and agreeing with regulatory agencies, such as FDA (US), EMA (EU), and PMDA (Japan).

Dermal Drug Delivery

Tapash K. Ghosh
Dermal Drug Delivery Book PDF

Author : Tapash K. Ghosh
Publisher : CRC Press
Page : 409 pages
File Size : 44,5 Mb
Release : 2020-01-21
Category : Medical
ISBN : 9781315356648

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Dermal Drug Delivery by Tapash K. Ghosh Pdf

With the continued advancement of better-quality control and patient outcome reporting systems, changes in the development, control, and regulation of all pharmaceutical delivery systems including transdermal and topical products have been happening on a continuous basis. In light of various quality issues that have been reported by patients and practitioners resulting in the recall or removal of products from the market, both the pharmaceutical industries and regulatory agencies have been adopting new measures to address these issues. With chapters written by experts in this field, this book takes a 21st century multidisciplinary and cross-functional look at these dosage forms to improve the development, design, manufacturing, quality, clinical performance, safety, and regulation of these products. This book offers a wealth of up-to-date information organized in a logical sequence corresponding to various stages of research, development, and commercialization of dermal drug delivery products. The authors have been carefully selected from different sectors of pharmaceutical science for their expertise in their selected areas to present objectively a balanced view of the current state of these products development and commercialization via regulatory approval. Their insights will provide useful information to others to ensure the successful development of the next generation dermal drug products. Key Features: Presents current advancements including new technologies of transdermal and topical dosage forms. Presents challenges in the development of the new generation of transdermal and topical dosage forms. Introduces new technologies and QbD (quality by design) aspects of manufacturing and control strategies. Includes new perspectives on pre-clinical and clinical development, regulatory considerations, safety and quality. Discusses regulatory challenges, gaps, and future considerations for dermal drug delivery systems.

Frontiers in Drug Design & Discovery: Volume 10

Atta-ur-Rahman,M. Iqbal Choudhary
Frontiers in Drug Design Discovery Volume 10 Book PDF

Author : Atta-ur-Rahman,M. Iqbal Choudhary
Publisher : Bentham Science Publishers
Page : 261 pages
File Size : 41,9 Mb
Release : 2021-02-03
Category : Medical
ISBN : 9789811421556

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Frontiers in Drug Design & Discovery: Volume 10 by Atta-ur-Rahman,M. Iqbal Choudhary Pdf

Frontiers in Drug Design and Discovery is a book series devoted to publishing the latest and the most important advances in drug design and discovery. Eminent scientists have contributed chapters focused on all areas of rational drug design and drug discovery including medicinal chemistry, in-silico drug design, combinatorial chemistry, high-throughput screening, drug targets, and structure-activity relationships. This book series should prove to be of interest to all pharmaceutical scientists who are involved in research in drug design and discovery and who wish to keep abreast of rapid and important developments in the field. The tenth volume of this series brings together reviews covering topics related to the treatment of neoplasms, systems biology, respiratory diseases among others. Topics included in this volume are: - Recombinant Protein Production: from Bench to Biopharming - Plant Virus Nanoparticles and Virus like Particles (VLPs): Applications in Medicine - MAO Inhibitory Activity Of 4, 5-Dihydro-1 HPyrazole Derivatives: A Platform To Design Novel Antidepressants - Flavonoids Antagonize Effects of Alcohol in Cultured Hippocampal Neurons: A Drug Discovery Study - Hybrid Smart Materials for Topical Drug Delivery: Application of Scaffolds.

Biotechnology

Ronald P. Evens
Biotechnology Book PDF

Author : Ronald P. Evens
Publisher : CRC Press
Page : 182 pages
File Size : 55,8 Mb
Release : 2020-06-04
Category : Medical
ISBN : 9780429678684

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Biotechnology by Ronald P. Evens Pdf

The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies. Features Comprehensive coverage of biotechnology science topics used in development and manufacturing Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved

GMP Audits in Pharmaceutical and Biotechnology Industries

Mustafa Edik
GMP Audits in Pharmaceutical and Biotechnology Industries Book PDF

Author : Mustafa Edik
Publisher : CRC Press
Page : 474 pages
File Size : 40,9 Mb
Release : 2024-06-28
Category : Medical
ISBN : 9781003814047

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GMP Audits in Pharmaceutical and Biotechnology Industries by Mustafa Edik Pdf

The fact that good manufacturing practice (GMP) audits in the pharmaceutical and biotechnology industries have to be evaluated, and with very limited resources, has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations that are required to implement FDA, EMA, MHRA, WHO, TGA, and PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities. Features • An essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. • Anyone working in the manufacturing sector needs to be aware of GMP, be able to identify operational flaws as well as legal violations, and have a clear understanding of how to meet GMP standards. • Assists readers in understanding the importance of GMP and how they can apply each aspect in their working environment. • Covers a global regulatory landscape. • Suitable for relevant degree courses including industrial pharmaceutics and pharmaceutical biotechnology.

Handbook of Pharmaceutical Granulation Technology

Dilip M. Parikh
Handbook of Pharmaceutical Granulation Technology Book PDF

Author : Dilip M. Parikh
Publisher : CRC Press
Page : 905 pages
File Size : 48,5 Mb
Release : 2021-05-11
Category : Medical
ISBN : 9781000366389

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Handbook of Pharmaceutical Granulation Technology by Dilip M. Parikh Pdf

Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies

Gene Delivery Systems

Yashwant Pathak
Gene Delivery Systems Book PDF

Author : Yashwant Pathak
Publisher : CRC Press
Page : 317 pages
File Size : 46,8 Mb
Release : 2022-07-01
Category : Medical
ISBN : 9781000580297

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Gene Delivery Systems by Yashwant Pathak Pdf

This unique volume in our Drugs and Pharmaceutical Sciences series covers the development of gene therapy today, the technology involved, clinical applications of siRNA, non-viral vector-based mRNA delivery using nanotechnology, and RNA based vaccines for treating the infectious diseases. It also presents the current application of the CRISPR/Cas9 gene-editing technique which has revolutionized genome editing and which was awarded the 2020 Nobel Prize in Chemistry. Several new drug delivery systems are explored for the applications of gene therapy. These are found to be useful in treating chronic illnesses, including cancer and infectious diseases. Key Features: Overview of the development of gene therapy Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing Presents CRISPR gene therapy recent trends and applications Discusses siRNA, mRNA, and DNA plasmids

Handbook of Drug Metabolism, Third Edition

Paul G. Pearson,Larry C. Wienkers
Handbook of Drug Metabolism Third Edition Book PDF

Author : Paul G. Pearson,Larry C. Wienkers
Publisher : CRC Press
Page : 755 pages
File Size : 43,5 Mb
Release : 2019-05-20
Category : Medical
ISBN : 9781482262049

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Handbook of Drug Metabolism, Third Edition by Paul G. Pearson,Larry C. Wienkers Pdf

This book continues to be the definitive reference on drug metabolism with an emphasis on new scientific and regulatory developments. It has been updated based on developments that have occurred in the last 5 years, with new chapters on large molecules disposition, stereo-selectivity in drug metabolism, drug transporters and metabolic activation of drugs. Some chapters have been prepared by new authors who have emerged as subject area experts in the decade that has passed since publication of the first edition.

Gene Delivery

Yashwant Pathak
Gene Delivery Book PDF

Author : Yashwant Pathak
Publisher : CRC Press
Page : 377 pages
File Size : 46,5 Mb
Release : 2022-06-29
Category : Medical
ISBN : 9781000594799

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Gene Delivery by Yashwant Pathak Pdf

Gene delivery is a transport of genes of therapeutic values into the chromosomes of the cells or tissues which can be targeted to replace the faulty genes. In last two decades lot of research efforts are dedicated to gene delivery for therapeutic applications. Today gene therapy is promising approach in treatment of genetic diseases including mitochondrial related diseases like blindness, muscular dystrophy, cystic fibrosis, and some cancers. Gene Delivery Systems: Nano Delivery Technologies observes the exploration of nanotechnology for gene therapy and gene delivery. Written by prominent authors in the field, this book covers various aspects of gene delivery including challenges in delivering gene therapy, advances in genome editing, RNA-based gene therapy, Green nanoparticles for oligonucleotide delivery. Additional features include" Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing. Includes knowledge of the current application of CRISPR/Cas9 gene-editing technique; an approach that has recently been given the Noble Prize. Examines the development of mRNA vaccines for Covid -19 in challenging pandemic scenario Discusses siRNA, mRNA, and DNA plasmids.

Percutaneous Absorption

Nina Dragićević,Howard Maibach
Percutaneous Absorption Book PDF

Author : Nina Dragićević,Howard Maibach
Publisher : CRC Press
Page : 1008 pages
File Size : 40,8 Mb
Release : 2021-07-30
Category : Medical
ISBN : 9780429511561

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Percutaneous Absorption by Nina Dragićević,Howard Maibach Pdf

Updating and expanding the scope of topics covered in the previous edition, Percutaneous Absorption: Drugs, Cosmetics, Mechanisms, Methods, Fifth Edition supplies new chapters on topics currently impacting the field including cutaneous metabolism, skin contamination, exposure to protein allergens, in vitro absorption methodology and the percutaneous absorption of chemical mixtures. Complete with studies on the role of the skin as a key portal of entry for chemicals into the body, this book serves as a detailed reference source for recent advances in the field, as well as an experimental guide for laboratory personnel. Key Features: Details in vivo and in vitro methods for measuring absorption, dermal decontamination, mechanisms of transdermal delivery, and the relationship of transepidermal water loss to percutaneous absorption Considers a range of mathematical models, the safety evaluation of cosmetic ingredients, the absorption of hair dyes, nanoparticles for drug delivery, and other novel methods of drug delivery Discusses topics including skin metabolism, the skin reservoir, and the effects of desquamation on absorption

Filtration and Purification in the Biopharmaceutical Industry, Third Edition

Maik W. Jornitz
Filtration and Purification in the Biopharmaceutical Industry Third Edition Book PDF

Author : Maik W. Jornitz
Publisher : CRC Press
Page : 673 pages
File Size : 47,8 Mb
Release : 2019-06-26
Category : Business & Economics
ISBN : 9781351675697

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Filtration and Purification in the Biopharmaceutical Industry, Third Edition by Maik W. Jornitz Pdf

Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.

The Art and Science of Physiologically-Based Pharmacokinetics Modeling

Rodrigo Cristofoletti,Amin Rostami-Hodjegan
The Art and Science of Physiologically Based Pharmacokinetics Modeling Book PDF

Author : Rodrigo Cristofoletti,Amin Rostami-Hodjegan
Publisher : CRC Press
Page : 357 pages
File Size : 47,7 Mb
Release : 2024-07-15
Category : Medical
ISBN : 9781040033128

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The Art and Science of Physiologically-Based Pharmacokinetics Modeling by Rodrigo Cristofoletti,Amin Rostami-Hodjegan Pdf

This state-of-the-art text describes the science behind the system and drug-dependent components of PBPK models, its applications in translational and regulatory science, e.g., guiding drug discovery and development, and supporting precision medicine initiatives. To incorporate state-of-the-art knowledge, each chapter is written by leaders in the field and illustrated by clear case studies. Connecting basic and applied science, this book explores the potential of PBPK modeling for improving therapeutics and is designed for a wide audience encompassing graduate students as well as biopharmaceutics scientists and clinical pharmacologists. Features: 1. Provides a basic understanding of the physiologically-based pharmacokinetic modeling and its applications 2. Assists the reader in understanding product performance to allow for rapid product development and establish bioequivalence 3. Well-constructed content and added value of real examples 4. Illustrates how using available resources via modeling and simulation leads to a reduction in the costs related to drug development, which directly affects the costs to patients

Compounded Topical Pain Creams

National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams
Compounded Topical Pain Creams Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams
Publisher : National Academies Press
Page : 353 pages
File Size : 46,8 Mb
Release : 2020-07-21
Category : Medical
ISBN : 9780309672184

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Compounded Topical Pain Creams by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams Pdf

Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medicationsâ€"medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.